Shots - Health Blog
2:03 pm
Tue July 10, 2012

When Does An App Need FDA's Blessing?

Originally published on Tue July 10, 2012 6:34 pm

Bernard Farrell obsesses over every bite he eats, every minute of exercise he gets, and everything that stresses him out. And, more than anything else, Farrell obsesses over his blood sugar.

He has to. Farrell, 55, has Type 1 diabetes.

"Pretty much everything affects our blood sugar," says Farrell, of Littleton, Mass.

So Farrell recently started using his phone to help him make sense of all the information he collects all day long. "I use a couple of pieces of software on my Android phone, mostly to track blood glucose readings, and also to help me figure out the number of carbohydrates in some food I might be eating," he said. "Because I have to know that in order to give myself the right amount of insulin."

The apps are among thousands that are flooding the market these days. Many are designed to help people take better care of themselves by, for example, counting calories and calculating body mass index.

Some apps, like Runkeeper and MapMyFitness, use the GPS tracker and the accelerometer in your smartphone to help with your exercise routine. Others help people look up symptoms, check drug side effects or locate. Some even measure blood pressure and blood sugar and send the readings off to the doctor.

"Mobile technology is a true game changer for health care," says Dr. Joseph C. Kvedar, founder of the Center for Connected Health in Boston. "It enables us to use that tiny computer in your hand to connect with you at any moment when we need to."

But does somebody need to check these things to make sure they work?

After all, we're not talking about apps that help you find a good restaurant or calculate your mortgage. These apps sometimes help make important decisions — sometimes life-and-death decisions.

"The ones that worry me are ones for instance where you can take an image of a skin lesion and then map it back to a database in the cloud and be told whether it should be evaluated for a melanoma or not," says Kvedar, a dermatologist by training. "It just seems a little scary right how to have software making decisions about moles."

Others calculate how much blood thinner to give heart attack patients, interpret blood tests in the emergency room — even help read X-rays, ultrasounds and CT scans.

As a result, the Food and Drug Administration has concluded that at least some apps should undergo review by the agency before being permitted on the market. "There are many mobile apps that are on the market that are medical devices," Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health. "There are apps today that change a mobile platform into an EKG machine. When it's being used to diagnose patients, it's a medical device we believe subject to FDA oversight."

But Shuren stresses that the FDA has no plans to review most apps, such as those that help with wellness, healthier lifestyles. Same goes for thoseused to help patients manage their medical conditions. "The risk to patients are very, very low," he says.

Some app makers, however, say they can't be sure what's allowed. "The problem is now we live in this era of connected health where everything is being connected to everything else," said Bradley Merrill Thompson, a lawyer who represents some app makers. "So now that you've got this ecosystem where everything is connected to everything else. That's what creates this ambiguity with FDA."

Some worry that even the possibility of regulation will stifle innovation. "If FDA steps into this field it's going to create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space," said Dr. Scott Gottlieb of the American Enterprise Institute.

Shuren and other FDA officials said the agency is trying to walk a fine line between protecting patients without stifling innovation. By the end of the year, the agency hopes clarify how it will handle the explosion of mobile medical apps.

Copyright 2013 NPR. To see more, visit http://www.npr.org/.

Transcript

MELISSA BLOCK, HOST:

These days, it seems there's an app for everything and that includes apps to help people stay healthy. As NPR's Rob Stein reports, that's prompted a debate over when a medical app becomes a medical device.

ROB STEIN, BYLINE: Bernard Farrell obsesses over every bite he eats, every minute of exercise he gets, everything that stresses him out. And, more than anything else, Farrell obsesses over his blood sugar. He has to. He has Type I Diabetes.

BERNARD FARRELL: Pretty much everything affects our blood sugar, so if I get up in the morning, my blood sugar is going to be at some number. And then, depending on what I eat and how accurate I am with my insulin dosing, my blood sugar is likely to go up, but if I take too much, it may go down. And then, if I get to work and I'm all stressed out, it may go up. If I exercise, it may go down.

STEIN: So, Farrell recently started using his phone to help him make sense of all the information he collects all day long.

FARRELL: I use a couple of pieces of software on my Android phone, mostly to track glucose readings and also to help me figure out the number of carbohydrates in some food I might be eating because I have to know that in order to give myself the right amount of insulin.

STEIN: These apps are among thousands flooding app stores these days. Many are designed to help people take better care of themselves. They count calories, calculate body mass index...

JOSEPH C. KVEDAR: And, of course, all manner of MapMyFitness, RunKeeper, all the ones that use your GPS tracker and the accelerometer on your phone is a tool to map your activity.

STEIN: That's Joseph Kvedar at Harvard Center for Connected Health.

KVEDAR: Mobile technology is a true game changer for health care. It enables us to use that tiny computer in your hand to connect with you at any moment when we need to.

STEIN: There are apps that'll remind you to take your medicine, look up symptoms, check side effects of drugs, help find the nearest specialist. Some even measure blood pressure and blood sugar and send the readings to your doctor. But the question is, does anybody need to check these things to make sure they really work? After all, we're not talking about apps that help you find a good restaurant or look up movie listings. These apps sometimes help make big decisions, sometimes life and death decisions.

KVEDAR: The ones that worry me are ones where you can take an image of a skin lesion and then map it back to a database in the cloud and be told whether it should be evaluated for melanoma or not. It just seems a little scary right now to have software making decisions about moles.

STEIN: Others calculate how much blood thinner to give heart attack patients, interpret blood tests in the emergency room, even help read x-rays, ultrasounds and CAT scans. Jeffrey Shuren says these kinds of apps should get a once-over from federal regulators. He's a top official at the Food and Drug Administration.

JEFFREY SHUREN: There are many mobile apps that are on the market that are medical devices. There are apps today that change a mobile platform into an EKG machine. When it's being used to diagnose patients, it's a medical device we believe subject to FDA oversight.

STEIN: But Shuren stresses that the FDA has no plans to review most apps.

SHUREN: We think most of the mobile apps out there should not have to comply with the FDA requirements. For example, mobile apps that are used for wellness, healthier lifestyles, many mobile apps that are being used to help patients manage their disease and their medical conditions. The risks to patients are very, very low.

STEIN: But some app makers say there's a huge gray zone, leaving them uncertain where they stand. Bradley Thompson represents app makers.

BRADLEY THOMPSON: The problem is now we live in this era of connected health where everything is being connected to everything else. So now that you've got this ecosystem where everything is connected to everything else, that's what creates this ambiguity with FDA.

STEIN: For example, Bernard Farrell - he's the patient with diabetes - wishes there was an app that could automatically combine the data from the device that measures his blood sugar with the information from another device that gives him his insulin and the information he collects about himself.

FARRELL: It would be enormously more helpful if I didn't have to enter the information, if it could be pulled out of the devices.

STEIN: Some worry that even the possibility of any FDA regulation could stifle innovation in the fast moving field. Scott Gottlieb is with the American Enterprise Institute.

SCOTT GOTTLIEB: The problem is that, if FDA steps into this field, it's going to create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space.

STEIN: The FDA says it's trying to walk a fine line, protecting patients without stifling innovation. By the end of the year, the agency hopes to clarify how it will handle the explosion of mobile medical apps.

Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.